MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926032220
Medical Device Problem Codes	Bent (1059); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mfr report#: 2134265-2018-00152.It was reported that stent damage, migration and explant occurred.The patient presented with acute spontaneous dissection of the ramus artery.The target lesion was 40mm long, extremely tortuous and had mild calcification in proximal segment.A non-bsc guidewire was placed and an over-the-wire non-compliant balloon catheter was advanced into the proximal section of the vessel.Then the non-bsc guidewire was taken out and injected through the lumen to confirm that it was luminal with the balloon.The wire was put back into the balloon catheter.After pre-dilation, a 2.25x32mm synergy drug eluting stent was placed in the distal ramus and then another 2.25x28mm synergy stent was place in the proximal ramus.A non-bsc extra support guidewire was placed to straighten out the vessel, then post-dilation was performed with a 2.50x15mm apex balloon in the overlapping segment of both stents.When it was dilating, under fluoroscopy they could see the tortuous vessel that straightened, it twisted.When pulling the extra support guidewire, it was locked down both stents and could not be removed from the stent.The stents seemed twisted like a candy wrapper entrapping the guidewire in the stent.Post-dilation was performed again.The stents twisted again and the guidewire would not come out.The patient was fine.At that time the guidewire started coming back on its own into the left main artery with the stents attached.The physician was able to pull everything back, disengage the guidewire and pull it into the aorta.An 8f guide catheter was advanced from the right groin of the right arm and a snare was put up there.The distal part of the guidewire and the stents were snared and pulled into the 8f guide catheter.The guidewire was taken out of the tuohy and was cut.Then the guidewire was pulled back through the arm.No patient injury was reported.The patient was fine and had no pain or blood pressure changes.The procedure was completed.The patient went to the floor over the weekend just to be monitored.The patient was released afterwards.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7213789
• Report Number: 2134265-2018-00213
• Device Sequence Number: 1185817
• Product Code: NIQ
• UDI-Device Identifier: 08714729840329
• UDI-Public: 08714729840329
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2018
• Device Model Number: H7493926032220
• Device Catalogue Number: 39260-3222
• Device Lot Number: 0021211206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR